Antibiotics for appendicitis No thanks

The long-awaited Finnish randomized controlled trial of antibiotics vs. surgery for appendicitis was just published in JAMA. Depending on your perspective, 73% of patients were successfully treated with antibiotics or 27% of patients failed antibiotics and needed surgery.

The good news is that it was a large multicenter study involving 273 patients randomized to surgery and 257 to antibiotics. Patients included in the study had uncomplicated appendicitis as diagnosed by CT scan.

The bad news is that the paper has many limitations.

Of the patients who underwent appendectomy as the primary treatment, only 15 (5.5%) had laparoscopic surgery. The authors state that open appendectomy was selected as the protocol operative technique because laparoscopic instruments may not be available worldwide and apparently many surgeons in Finland are not experienced in performing laparoscopic appendectomies.

In most Western countries, laparoscopic appendectomy is the procedure of choice. In the United States, at least 80% of all appendectomies (not just those done in patients with early or simple appendicitis) are done laparoscopically. Laparoscopic appendectomy has a much lower complication rate than open. This renders the comparison of complications of surgery (20.5%) and antibiotics (2.8%) in the Finnish randomized trial meaningless. The Finnish authors did not consider failure of antibiotic treatment a complication. Had they done so, the complication rate would have been higher for the antibiotic group.

The hospital length of stay for the surgery patients in the JAMA study was a median of three days. A paper from Texas published last year found that of 345 patients who had laparoscopic appendectomies for uncomplicated appendicitis, 88% were managed as outpatients. They spent a total of about eight hours in the hospital from admission to discharge and had a complication rate, including readmission, of 2.8%.

The antibiotic chosen for the in-hospital treatment in the JAMA study nonoperative group was ertapenem—a once-a-day drug that costs $80 per dose. How available is ertapenem in low- and middle-income countries?

The follow-up in the current paper was only one year. Is it realistic to expect that no more patients will have recurrences of appendicitis in the following years?

The inconvenience and costs of the extra hospitalization for the 27% of patients who failed antibiotic therapy were not addressed.

The stated goal of the trial was to prove the noninferiority of antibiotic therapy for appendicitis. By the authors own admission, the result failed to meet their prespecified criterion for noninferiority. In plain English, this means the trial showed antibiotic therapy is inferior to surgery for the treatment of uncomplicated acute appendicitis.

Early last year, I blogged about the potential problems with this study and said, "A randomized trial of antibiotics vs. surgery for uncomplicated appendicitis is underway in Finland. Judging from the wording of the abstract describing the trial, the authors are markedly biased toward the use of antibiotics. Despite this, lets hope it sheds some much needed light on this subject." Too bad that did not happen.

Other than Dr. Edward Livingston, a surgeon who wrote a favorable editorial accompanying the paper in JAMA, I do not know of any surgeons who would opt for antibiotics to treat appendicitis for themselves or their family members.

A more realistic randomized trial is planned by surgeons in Washington State. Until that study is published, I’ll stick with surgery for uncomplicated appendicitis.

Addendum: The spelling of ertapenem was corrected on 6/18/15.

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Questions about antibiotics vs surgery for acute appendicitis

A study from Finland suggesting that antibiotics may be a viable alternative to surgery for acute appendicitis has created a stir. As you might have expected, I had some concerns about the paper which you can read in my blog post here.

On Twitter, many surgeons have commented on both the paper and my post. Several interesting questions come to mind.

Based on this and other similar studies, is the treatment of acute appendicitis with antibiotics now a mainstream alternative to surgery?

Should surgeons now mention the Finnish study results during their informed consent discussions with patients?

Is CT scanning accurate enough to differentiate a reasonable percentage of uncomplicated appendicitis from more complex cases? Previous papers have reported conflicting data on this topic. Will this lead to more CT scanning (if that is even possible)?

What do patients want? In an effort to avoid surgery, are they willing to take a 25-30% chance of a recurrence of appendicitis?

Will patients be able to understand the distinction between complicated and uncomplicated appendicitis?

We all agreed that ertapenem is not a first-choice antibiotic in the United States. In fact, the real questions may be is a three-day hospitalization for intravenous antibiotics really necessary, or as is the case with acute sigmoid diverticulitis, would a course of oral antibiotics as an outpatient be sufficient to deal with an attack of uncomplicated appendicitis?

How will it work if antibiotics and surgery are considered equivalent treatments? Although I am retired, I think I am qualified to say that I would not have enjoyed going to an emergency department at 10 o’clock at night to see a patient with acute appendicitis who after a discussion, chooses to be treated with antibiotics. Should these medically-treated patients be admitted to surgery or another service? Should the emergency physician have the discussion with the patient and only call the surgeon if the patient elects to have an operation?

Is it appropriate for an anonymous blogger to be questioning the methods and results of a paper published in a top-tier journal such as JAMA?

What do you think about all of these questions?

Many thanks to the following for their input. If I omitted someone, I apologize. @jdimick1, @NirajGusani, @TomVargheseJr, @ChrisFriese_RN, @LVSelbs, @NatalieBlencowe, @JBMatthews, @ehldallas, @zuckerbraun, @SarahB_MD, @docaggarwal, @aneelbhangu, @smootholdfart, @DRSoup34, @hswapnil, @qdtrinh, @TimLaheyMD, @jonessurgery, @RogueRad, @DrKathyHughes, @putrescine, @krchhabra, @Apathetic_Cynic, @SimonRBarron

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Recognition

The following is based on an actual case that occurred a long time ago in a galaxy far, far away.

A 65-year-old man arrived in the emergency department by ambulance after being found unresponsive. His respiratory rate was 40/minute, heart rate was 170/minute, and temperature was 102.2°. He did not respond to Narcan or an ampule of 50% dextrose. Blood sugar was 600 mg/dL. The diagnosis of diabetic ketoacidosis was made. IV fluids and an insulin drip were given. After some hydration he became more alert and complained of abdominal pain. On examination, his abdomen was tender to palpation. Four hours after arrival, a surgical consultant was called and diagnosed an incarcerated inguinal hernia. Before the patient could be taken to surgery, he suffered a cardiac arrest and could not be resuscitated. Review of the case revealed that although blood cultures were drawn and were eventually positive, antibiotics had not been ordered.

What happened? The possibility that this patient was septic never occurred to the doctors managing the case. I am sure that if a scenario like this appeared on a test, those doctors would have immediately chosen the right antibiotics. Some doctors are "book smart" but cant deal with a real live patient.

Although the doctors didnt do a very thorough abdominal exam at first, the real problem here was recognition.

I was reminded of this case by a recent article about a 2013 paper that appeared in a journal called Human Factors. The paper, "The Effectiveness Of Airline Pilot Training for Abnormal Events," pointed out that pilots doing their periodic training know that certain crises—stalls, low-level wind shear, engine failures on takeoff—are part of every simulator session and will occur in predictable ways.

The authors presented those situations in unexpected ways, measured pilots reactions, and found that experienced pilots responded less skillfully.

From the paper: Our control conditions demonstrate that pilots’ abilities to respond to the “schoolhouse” versions of each abnormal event were in fine fettle. The problems that arose when the abnormal events were presented outside of the familiar contexts used in training demonstrate a failure of these skills to generalize to other situations.

They suggested four ways to improve training and testing.

1) Change it up. In other words, dont practice things the same way every time.

2) Train for surprise.

3) Turn off the automation. Dont let the pilots depend on automated systems to help them recognize what is going on because if those systems fail, pilots will have trouble dealing with the situation.

4) Reevaluate the idea of teaching to the test which can "present the illusion that real learning has taken place when in fact it has not."

Item #3 is particularly relevant because of some recent interest in the negative effects that automation is having on pilots and possibly society in general. The 2009 crash of an Air France plane into the South Atlantic Ocean has been analyzed in several recent publications. (Here and here)

The cockpit voice recorder transcript is chilling. In a storm, the autopilot failed, and the plane stalled. Three pilots failed to recognize what happened and did all the wrong things.

I have been saying for years that we need to teach med students and residents how to think. Recognition of rare events would be a good area to focus on.

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Take lecture notes on a laptop computer or use old fashioned longhand

A paper published last year in Psychological Science suggests that taking notes in longhand is the better choice.

The authors, from Princeton University and UCLA, performed three studies on college students. They found that even if multitasking and distractions were eliminated, “students who took notes on laptops performed worse on conceptual questions than students who took notes longhand.”

Previous research has shown that note taking enhances learning by both providing external storage of information for later review and “encoding,” that is, processing information and reframing it in one’s own words.

Although significantly more notes were taken by laptop users, they tended to be more like transcriptionists instead of thinking about and summarizing what they heard.

When tested on standardized lecture material, both groups did equally well on factual questions, but those who used longhand for note taking fared significantly better on questions dealing with concepts.

Even when students using laptops were instructed not to transcribe lectures verbatim, they were unable to do so.

Subjects were tested with and without studying their notes. Without studying before a test, scores did not differ between the two groups, but when studying was permitted, those who took longhand notes again performed better.

From the discussion section of the paper: “Although more notes are beneficial, at least to a point, if the notes are taken indiscriminately or by mindlessly transcribing content, as is more likely the case on a laptop than when notes are taken longhand, the benefit disappears.” [That run-on sentence was probably typed on a laptop.]

The authors concluded that laptops in classrooms may be doing more harm than good.

This dovetails nicely with my previous post on live-tweeting of conferences and lectures. People who live tweet claim the tweets can serve as notes. I doubt that. The live tweeters are deluding themselves. They are simply doing “play by play” of a session and are not likely to retain the information.

From a Guardian essay on this topic: A linguistic professor "conducted a survey of reading preferences among over 300 university students across the US, Japan, Slovakia and Germany. When given a choice between media ranging from printouts to smartphones, laptops, e-readers and desktops, 92% of respondents replied that it was hard copy that best allowed them to concentrate."

According to an article in the Wall Street Journal, smart pens can record what is written in longhand and convert it to digital text albeit with some difficulties and inaccuracies. Using a stylus on a tablet computer can also be done, but not as quickly as writing with a dumb pen on paper.

Like reading a real book instead of a digital book, taking notes may be another area in which the gadgets lose.

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Live tweeting from ACSCC15

As many of you know, I have not been a fan of live tweeting conferences. I blogged about the issue last year (here and here) and received a lot of feedback about the posts, most of it strongly opposing my views.

Vigorous live tweeting from the American College of Surgeons Clinical Congress (#ACSCC15) in Chicago is underway. Here are a couple of examples of tweets from that meeting. Twitter handles are blocked to protect the innocent (or guilty).

First, the good. Here is a nice montage showing what surgical program directors are looking for in residency applicants.

The photos are in focus and well-positioned. Anyone not in the audience for the talk can get something useful from this tweet. My one complaint -- we do not know who the speaker is. That information may have been provided in an earlier tweet, but this retweet is the only one I saw.

Now, the bad. The slide below probably contained some valuable information. Only the live audience knows for sure.

Since I havent seen all of the live tweets from #ACSCC15, I cant say which type is prevalent.

I can only hope its the former.

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Antibiotics vs surgery for appendicitis Its time for a randomized trial

Maybe youve heard that there is a growing debate about whether antibiotics are as good or better than surgery for treating appendicitis.

So far there have been several studies from Europe showing that antibiotics may be safely used to treat appendicitis in many cases. However, the studies have involved small numbers of patients and have exhibited some flaws in their methods. A few studies from the US have been published, but they were not randomized or prospective.

I have blogged about some of these studies on three occasions. If you would like to read these posts, click on their titles.

Antibiotics instead of surgery for appendicitis? Im still not convinced

Antibiotics instead of surgery for appendicitis? No way

Antibiotics instead of surgery for appendicitis? I don’t think so.

A group of surgeons in Washington State are putting together what will be the first randomized prospective trial of antibiotics vs. surgery for appendicitis in the United States. In order to obtain a grant from the Patient-Centered Outcomes Research Institute to help fund the project, the investigators must demonstrate that people in this country would be willing to participate in such a study.

To help determine the level of interest, they have written a brief explanation of why this study is being proposed. It parallels my thinking on the subject.

At the end of their post is a link to survey involving one question:

If you had appendicitis, would you be willing to join a study that would randomize you (a 50% chance, or flip of a coin) to “surgery ” or “antibiotics?”

You dont have to read the Washington researchers post to take the survey.

You may click here to answer that question. Thanks.

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The Surgeon Scorecard My analysis

Ive got nothing against ProPublica. If a valid way to rate surgeons is ever discovered, I would support it completely. However, ProPublicas Surgeon Scorecard is not the answer.

I keep hearing its defenders say, "Some data is better than no data at all." I disagree strongly with that. To me, bad data is worse than no data at all. People with much more statistical sophistication than I have pointed out the flaws in the scorecard.

Digression: Having written many posts about statistics, I can tell you that the mere mention of the word drives readers away about as fast as if you were to yell "Fire" in a crowded theater.

I want to focus on a different area. The scorecard has created a lot of chatter on Twitter, and just about everyone I know has blogged about it.

This reminds me of a couple of posts I wrote back in 2011. [Links here and here.] I pointed out that Twitter might not be as important as those of us who use it think it is.

While we were busy arguing about the merits of the scorecard on Twitter, Im not so sure what the general public was doing.

For example, ProPublica says the Surgeon Scorecard has had over 1 million visitors since its launch. That sounds like a lot until you consider that the current population of the United States is estimated at 321 million. So 1 million people would be 0.3%. We do not know how many of those 1 million were unique visitors. It could be that many of them were doctors looking for their own statistics and bloggers looking for ideas.

That the public may not care was reinforced by a rather tepid response to the ProPublica AMA (Ask Me Anything) on Reddit today.

By 1:00 PM EDT, which was two hours into the AMA, there were 80 comments, 31 of which were by ProPublica staff or the spine surgeon who had consulted on the scorecards methods.

Just to give you some perspective, an AMA last year by a guy with two penises drew 17,134 comments.

Because the demographic is skewed toward younger people, perhaps Reddit may not have been the right venue. Although Reddit boasts 169 million unique visitors per month, the most recent figures show that 33% of the Reddit users are mostly men between 18 and 49 years old. Those under 18 are not counted but represent "a substantial percentage of Reddit users."

My two favorite questions asked of ProPublica were "How can I tell if my doctor is capable of making an error?" and "Do you fix the leg which is broken completely?" [Did the question refer to a leg that was completely broken, or did it mean should the leg be completely fixed?]

What have we learned here? Its hard to say.

If you want to read a measured critique of the scorecard, go to Dr. John Mandrolas piece on Medscape.

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